FDA.reportPublic FDA data

Application 205136

Type
ANDA
Sponsor
INDICUS PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo
002MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52536-129Meclizine hydrochlorideMeclizine hydrochlorideWilshire Pharmaceuticals IncANDACurrent
52536-129Meclizine hydrochlorideMeclizine hydrochlorideWilshire Pharmaceuticals IncANDACurrent
52536-133Meclizine hydrochlorideMeclizine hydrochlorideWilshire Pharmaceuticals IncANDACurrent
52536-133Meclizine hydrochlorideMeclizine hydrochlorideWilshire Pharmaceuticals IncANDACurrent
52536-137Meclizine hydrochlorideMeclizine hydrochlorideWilshire Pharmaceuticals IncANDACurrent
52536-137Meclizine hydrochlorideMeclizine hydrochlorideWilshire Pharmaceuticals IncANDACurrent
71205-374Meclizine hydrochlorideMeclizine hydrochlorideProficient Rx LPANDACurrent
71205-374Meclizine hydrochlorideMeclizine hydrochlorideProficient Rx LPANDACurrent